JP2009128199A - Analytical processing system - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To solve the problem that an analytical processing system which performs the process of judging a system compatibility from a result of an analysis performed for a prescribed number of samples, makes an analyzing apparatus difficult to improve its operation rate and makes operations of generating and changing a batch table troublesome, since each judgement is made by analyzing a result when completing each analysis, and then that the analysis of the next sample is initiated. <P>SOLUTION: The analytical processing system is configured so as to comprise the batch table defining one or more analyses including the step of judging the system compatibility performed in order to check normality of the system and the samples, an analyzing apparatus controlling section for controlling the analyzing apparatus so as to continuously perform a series of analyses including judging the system compatibility for one or more samples from a procedure described on a schedule defining the batch table hierarchically, and an operation deciding section for deciding the next analysis step on the basis of the above schedule and above judging/analyzing result of the system compatibility. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

The present invention relates to an analysis processing system for executing so-called batch processing for continuously automatically analyzing and automatically analyzing a plurality of specimens (samples).
In this specification, “analysis” refers to various measurements and measurements performed on a sample, and “analysis” refers to data analysis performed on data obtained as a result of analysis. . The notation “analysis / analysis” means “analysis or analysis”.

In an analyzer such as a chromatograph, when performing analysis and data analysis processing for a plurality of samples, a batch table for analysis is designated in advance, and samples are collected in order by the autosampler according to this batch table for analysis. Executing and continuously executing analysis processing using data acquired by analysis.
In addition, for a plurality of data that has already been analyzed, data may be reanalyzed according to a batch table designated in advance.
As an example of the prior art related to such batch processing, Patent Document 1 discloses an invention capable of automatically creating a batch table.

  In a batch processing system that analyzes and analyzes multiple samples continuously, various types of checks are made to check whether there are any problems with the sample or system prior to the execution of the final (that is, target sample) analysis. In general, a preliminary analysis is performed or an abnormal value of an analysis result is determined. In this specification, this confirmation is called “determination of system compatibility”.

Examples of analysis and analysis for determining system suitability include the following.
・ Noise and drift check ・ S / N ratio, LOD (Limit of Detection) / LOQ (Limit of Quantitation) measurement ・ Column performance calculation ・ System reproducibility check

Japanese Patent Laid-Open No. 5-256840

The system suitability determination as described above is performed based on the analysis result of a single sample (for example, “noise and drift check”) and based on the analysis result of a plurality of samples (for example, “system reproduction”). Sex check ”).
When “system reproducibility check” is performed, analysis is performed based on the analysis results of a predetermined number of times (for example, 6 times). If the target peak retention time or area% RSD does not meet the criteria, batch analysis is performed. The set to be performed is judged as rejected.

  Conventionally, when determining system suitability based on multiple analysis results, (a) Sample analysis → (b) Analysis of analysis data → (c) Determination of analysis results → (If there is no problem) Next sample It has been performed to repeat the procedure of analysis. According to this method, after the analysis of (a) is completed, since the processing of (b) and (c) is performed while the analyzer is temporarily stopped, the operating rate of the analyzer cannot be increased. was there.

  Conventionally, when determining system suitability or measuring an actual sample, a batch table containing instructions over multiple lines is used to set the calculation method and conditional branch settings for each line. Is going. Therefore, when performing analysis and determination based on a plurality of analysis results, there is a problem that creation and setting of a batch table is very troublesome. Moreover, the possibility that a setting error will occur cannot be denied.

  The present invention has been made to solve the above-described problems, and an object of the present invention is to operate an analysis apparatus in an analysis processing system that executes batch processing including a step of determining suitability of the system. The purpose is to increase the rate and to easily manage the system compatibility determination process.

The analysis processing system according to the present invention configured as described above,
An analysis processing system for continuously analyzing or analyzing a plurality of samples by controlling a connected analyzer,
a) a batch table that defines one or more analysis / analysis steps including a step of determining system suitability to be performed to confirm the normality of the system and sample;
b) An analyzer that controls the analyzer to continuously execute a series of analyzes including system suitability determination for one or a plurality of samples based on a procedure described in a schedule in which the batch table is hierarchically defined. A control unit;
c) an operation determining unit that determines a next analysis / analysis step based on the system suitability determination analysis result and the schedule;
It is characterized by including.

  Unlike the conventional analysis / analysis based on a batch table composed of one line and one line as in the prior art, the analysis processing system according to the present invention provides a schedule in which steps constituting large processing contents are defined. Along with the process. The procedure to be performed in each step and the procedure showing the details of the sample to be used are acquired by referring to the description included in the schedule or the description in another definition file. When determining system suitability based on a plurality of analysis results, instead of making a determination for each analysis of one sample as in the past, analysis of a plurality of samples is performed continuously. . Therefore, it is possible to reduce the waiting time of the analyzer and improve its operating rate. In other words, this has the effect of improving the throughput of the entire analysis system.

  Further, in the analysis processing system according to the present invention, it is only necessary to specify a procedure such as a calculation method for one step, that is, for a whole series of samples to be subjected to batch processing. Thus, settings such as step order change and branch processing adjustment are greatly simplified, and mistakes are prevented.

  Hereinafter, an embodiment of an analysis processing system according to the present invention will be described. FIG. 1 is a diagram showing a functional configuration of an analysis processing system according to the present invention. As shown in FIG. 1, the analysis processing system of the present invention is connected to an analysis apparatus 2.

  The analysis processing system 1 according to the present invention is a computer, and includes a CPU (Central Processing Unit), a storage device such as a hard disk and a flash memory, an input unit such as a memory, a keyboard and a mouse, a display unit such as a CRT monitor and a liquid crystal monitor, and the like. It shall be equipped with. In the storage device, batch set information (non-existing) including schedules (details will be described later) and definitions (sample names, IDs, sample types, method files, data files, etc.) related to a plurality of samples to be subjected to batch processing. A program for executing analysis / analysis processing is stored.

  The functional configuration diagram of the analysis processing system 1 in FIG. 1 includes an analysis device control unit, a data processing unit, and an operation determination unit. These are generally software that is executed by the CPU of the analysis processing system 1 executing a program. It is a functional configuration that is achieved manually.

The schedule is a definition file in which batch tables are defined hierarchically and the execution order of analysis / analysis is described for each step. In the present invention, the schedule includes the step of determining system suitability as described above.
In this example, as an example of the schedule,
1) Noise and drift check
2) System reproducibility check
3) Consider what consists of three steps of analysis of real samples.

  It is assumed that the schedule also includes a detailed procedure including specific parameters on how to perform analysis / analysis of each step. However, the procedure in each step may be described in a definition file (may be batch set information) provided not in the schedule.

  In addition, the schedule includes the reference values for system suitability, and actions to be taken for the judgment results (pass, fail, Any, etc.) (stop, pause, jump, remeasurement, warning notification, etc.) be able to.

  The user uses the input unit or the like of the control unit 1 in advance to determine what steps are included in the schedule and what procedures (specimen type, measurement conditions, etc.) they have. It shall be created by

  The analyzer 2 in the analysis processing system according to the present invention is particularly preferably a chromatographic analyzer such as GC, LC, GC-MS, LC-MS, but is not limited thereto, and various analyzers are available. Or a measuring device.

  Hereinafter, a batch analysis process for a plurality of samples executed by the analysis processing system according to the present invention will be described with reference to FIG. 2 which is a flowchart. In this example, it is assumed that the analysis / analysis composed of the above three steps is described in the schedule.

First, in step S1, one sample is analyzed based on the description of the schedule (by the operation determining unit referring to the schedule) (by the analyzer control unit giving a predetermined control instruction to the analyzer), Next, the data processing unit analyzes the analysis result output from the analyzer, thereby calculating noise and drift. Next, in step S1J, the operation determination unit determines whether the result is acceptable or not by comparing the result (system suitability determination analysis result) with a reference value. In the case of failure (No in step S1J), the currently executing analysis process is terminated. At this time, you may make it display the message which notifies that it is disqualified on a display part.
When the calculation result of noise and drift acquired in step S1 satisfies the reference value (Yes in step S1J), the process proceeds to step S2 (the operation determining unit gives an instruction regarding the next step described in the schedule). read out).

  In step S2, the reproducibility of the system is checked based on the schedule description. When checking the reproducibility of the system in the schedule of this embodiment (or other files), the analysis is performed 6 times, and the retention time (retention time) and area% RSD (relative standard deviation) are calculated. The calculation is described. Accordingly, the analyzer control unit appropriately controls the analyzer 2 to execute the analysis six times in succession. At this time, the analyzer control unit refers to the description of the schedule (or other file) for the type of sample used in the reproducibility check of the system and the measurement conditions thereof (that is, the procedure).

  The analysis device 2 transmits six analysis results to the data processing unit in order or in a batch. Upon receiving this analysis result (system suitability determination analysis result), the data processing unit performs analysis by calculating% RSD of retention time and area. The operation determination unit determines whether the system suitability in this step is acceptable or not by comparing the result with the reference value. If it is unacceptable (No in step S2J), the operation is currently being executed. The analysis process ends. If it is acceptable (Yes in step S2J), the operation determining unit reads an instruction related to step S3, which is the next step described in the schedule.

  The schedule describes execution of analysis of the actual sample as the next step. Therefore, the operation determination unit reads the procedure for analyzing the actual sample by referring to the batch set information, first creates a calibration curve, then analyzes the unknown sample, and performs quantification (step S3).

  The analysis processing system according to the present invention has been described above with an example. However, the above is an example, and it is a matter of course that changes and improvements may be appropriately made within the spirit of the present invention.

The figure which shows the function structure of the analysis processing system which concerns on this invention. The flowchart of the analysis process by the analysis processing system which concerns on this invention.

Explanation of symbols

1 ... Analysis processing system 2 ... Analyzer

Claims (1)

An analysis processing system for continuously analyzing or analyzing a plurality of samples (hereinafter referred to as “analysis / analysis”) by controlling a connected analyzer,
a) a batch table that defines one or more analysis / analysis steps including a step of determining system suitability to be performed to confirm the normality of the system and sample;
b) An analyzer that controls the analyzer to continuously execute a series of analyzes including system suitability determination for one or a plurality of samples based on a procedure described in a schedule in which the batch table is hierarchically defined. A control unit;
c) an operation determining unit that determines a next analysis / analysis step based on the system suitability determination analysis result and the schedule;
The analysis processing system characterized by including.

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